Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain

NCT06165991 · tracked via the Priya Life Science China tracker

Sponsor

Yongtao Sun

Phase

Phase 4

Started

2024-06-01

Last updated

2026-01-09

Condition(s) studied

Thoracic Paravertebral BlockPostoperative AnalgesiaThoracoscopic Lobectomy

Investigational drug(s) / intervention(s)

GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;Group A: bupivacaine hydrochloride; →

GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;: Group B::Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride.

Group A: bupivacaine hydrochloride;: Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).

Study summary

I. Research purpose

1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy

1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 1\) Age ≥18 years old; 2\) Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted); 3\) American Society of Anesthesiologists (ASA) Grade I - III; 4\) Voluntarily participate in the study and sign the informed consent. Exclusion Criteria: * 1\) Pregnant or lactating women; 2\) Pulmonary wedge-shaped resection; 3\) ≥2 thoracic drainage tubes; 4\) Abnormal liver function: ALT and/or AST\>2×ULN, or TBIL≥1.5×ULN; 5\) Renal function impairment (serum creatinine \>176μmol/L), or received dialysis treatment within 28 days before surgery; 6\) Participate in another research trial involving an investigational drug within 6 months; 7\) A history of drug or alcohol abuse; 8\) Long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month); 9\) History of allergy to local anesthetics or one of the investigational drugs; 10\) Uncontrolled mental or neurological symptoms.

Primary outcome measure(s)

area under the NRS score curve (AUC) for resting — 48hours postoperative
area under the NRS score curve (AUC) for resting and active 48 hours after surgery

Trial sites (1)

Facility	City	Region	Status
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06165991 on ClinicalTrials.gov ↗ ← All trials in China